So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020

Описание: FDA provides a cursory overview of applicant responsibilities following NDA approval. Discussed are requirements that apply to all NDA applications and additional post-approval activities that can occur, including changes to an existing NDA, submission of supplements, and potential additional postmarketing obligations (e.g., PMCs, PMRs, REMS, etc.).

Presenter:
Lawrence Allan, Regulatory Health Project Manager
Business Process Operations Staff
Office of New Drugs (OND) | CDER
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